(14 days)
Not Found
No
The device description and intended use focus solely on protocol conversion and data transmission, with no mention of AI or ML capabilities.
No
The device is a protocol converter that facilitates data exchange between medical devices and a bedside monitor; it does not directly provide therapy.
No
The device is a protocol converter that transmits data from other medical devices to a bedside monitor for display. It does not generate diagnostic information itself.
No
The device description explicitly mentions "Attachment cables specific to third party devices are offered as accessories," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter's function is to convert data from other medical devices (like ventilators and monitors) into a standard format for display on a bedside monitor. It does not perform any tests on patient samples.
- Intended Use: The intended use clearly states it's for connecting and displaying data from other medical devices.
- Device Description: The description confirms it transforms data, not analyzes biological samples.
Therefore, this device falls under the category of a medical device used for data communication and display, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices such as Siemens SV300™ ventilator, Baxter Vigilance™ blood gas/continuous cardiac output monitor, Siemens SV900™ ventilator, Puritan Bennett 7200™ ventilator, and the Draeger Evita IITM, Draeger Evita IV™ and Draeger Babylog™ ventilators that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.
The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter is indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that the Siemens SV300™ ventilator, Baxter Vigilance™ blood gas/continuous cardiac output monitor, Siemens SV900™ ventilator, Draeger Evita II™, Evita IVTM, and Draeger Babylog™ ventilators, and Puritan Bennett 7200™ ventilator should be connected to the Siemens SC9000/SC9015 Bedside Monitor for display.
Product codes
73 DQA
Device Description
The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generated by third party devices (e.g. ventilators, SvO2 devices and infusion pumps) into a common format per the IEEE 1073 Medical Information Protocol and transmits this data to the Siemens SC9000/SC9015 Bedside Monitor. Attachment cables specific to third party devices are offered as accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals (Physician, Nurse, Technician) / an environment where patient care is provided
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
3)22 368 Amendment Siemens SC9000/SC9015 Medical Information Bus (MIB) Protocol Converter
510(k) AMENDMENT SUMMARY
as required per 807.92(c)
- Submitters Name, Address:
- 4 1997
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Jacqueline E. M. Emery Date amendment to 510(k) K970368 was prepared: August 8, 1997
Trade Name, Common Name and Classification Name: 3.
A. Trade Name: (Same as original submission)
Siemens SC9000/ SC9015 Series Medical Information Bus (MIB) Protocol Converter [510(k) K970368 cleared May 6, 1997]
- B. Common Name, Classification Name, Class and Regulation Number:
(Same as original submission)
| Common Name | Classification
Number | Class | Regulation Number |
|---------------------------------------------|--------------------------|-------|-------------------|
| Transducer Signal amplifier and conditioner | 73 DQA | II | 21 CFR 870.2060 |
- Predicate Device Identification: (Same as original submission) 4. Hewlett-Packard Model M1032A Vuelink Interface Plug In Module cleared under 510(K) number: K923682
-
- Device Description: (Same as original submission)
The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generated by third party devices (e.g. ventilators, SvO2 devices and infusion pumps) into a common format per the IEEE 1073 Medical Information Protocol and transmits this data to the Siemens SC9000/SC9015 Bedside Monitor. Attachment cables specific to third party devices are offered as accessories.
6. Intended Use:
The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices such as Siemens SV300™ ventilator, Baxter Vigilance™ blood gas/continuous cardiac output monitor, Siemens SV900™ ventilator, Puritan Bennett 7200™ ventilator, and the Draeger Evita IITM, Draeger Evita IV™ and Draeger Babylog™ ventilators that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.
1
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)
1
7. Table of Device Similarities and differences to predicate device (Same as original submission)
| Substantial Equivalent Device | Applicant | |
|---|---|---|
| Hewlett Packard Co | Siemens Medical Systems | |
| Model MI032A VueLink Module | SC9000/9015 Series Medical | |
| Information Bus (MIB) Protocol | ||
| Converter (Amendment) | ||
| Manufacturer | Hewlett Packard | Siemens Medical Systems - |
| Electromedical Systems Group, PCS | ||
| 510(k) Number | K923682 | K970368 K973222 |
| Intended Use | Provides an external device interface | |
| capability to third party devices that | ||
| have a serial RS-232 and/or analog | ||
| output | Same | |
| Intended Population | NA | |
| Not connected to patients | Same | |
| Intended Environment | OR or ICU | Same |
| Input port | RS-232, Analog, Analog/Digital | |
| combination | Same | |
| Output port | HP specific | IEEE 1073 (MIB connector) |
Assessment of non-clinical performance data for equivalence: (Same as original submission) 8. Substantial equivalence is claimed to the Hewlett Packard Model M1032A VueLink Interface Plug-In Module cleared under 510(k) number K923682.
- Assessment of clinical performance data for equivalence: Not applicable 9. (Same as original submission)
-
Biocompatability: Not applicable (Same as original submission)
-
Sterilization: Not applicable (Same as original submission)
-
Standards and Guidances: (Same as original submission) Currently, there are no FDA standards for this device. However, the Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter complies with:
1073.3.1 - 1994 IEEE Standard for Medical Device Communications -Transport Profile - Connector Mode -
- 1073.4.1 1994 IEEE Standard for Medical Device Communications ﺳ Physical Layer Interface - Cable Conn .
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)
2
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. David Simard ~ · · · · · · Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923
K973222 Re: Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter for the Puritan Bennett 7200™, the Draeger Evita II™, IV™, Babylog™, and Siemens SV900™ Ventilators Requlatory Class: II (two) Product Code: 73 DQA Dated: August 18, 1997 Received: August 21, 1997
Dear Mr. Cohen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. David Simard
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Device Name:__________________________________________________________________________________________________________________________________________________________________ Protocol Converter
Indications for Use:-- ...... ................................................................................................................................................
The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter is indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that the Siemens SV300™ ventilator, Baxter Vigilance™ blood gas/continuous cardiac output monitor, Siemens SV900™ ventilator, Draeger Evita II™, Evita IVTM, and Draeger Babylog™ ventilators, and Puritan Bennett 7200™ ventilator should be connected to the Siemens SC9000/SC9015 Bedside Monitor for display.
MRI Compatibility Statement:
The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter is not compatible for use in an MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | |
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices |
510(k) Number_________________________________________________________________________________________________________________________________________________________________